Factor XA - Inhibition in RENal Patients With Non-valvular Atrial Fibrillation - Observational Registry

Completed

• Conditions: Non-valvular Atrial Fibrillation (NVAF); Chronic Kidney Disease (CKD)

• Registration Number: NCT02663076
• Lead Sponsor: GWT-TUD GmbH

Brief Summary

The multicenter registry will collect clinical data from 1600 patients with non valvular atrial fibrillation (NVAF) and chronic kidney disease (eGFR 15-49 mL/min per 1.73 m2).

The overall objective of this registry is to assess chronic kidney disease (CKD) progression and clinical outcomes with regard to anticoagulation strategies in NVAF patients with eGFR 15-49 mL/min per 1.73 m2 in routine clinical practice.

Detailed Description

This is a prospective registry allowing a structured, non-interventional collection of data. Participating physicians will not be subject to any instructions with regard to the diagnosis and therapy of their patients. All patient treatment is carried out within clinical routine, at the discretion of the physician and according to existing treatment guidelines.

This registry will be carried out as an investigator-initiated, multicentre, prospective, non-interventional and observational registry at approximately 160 sites in Germany, Austria, Switzerland, France, Belgium and Luxembourg.

The registry will collect clinical data of approximately 1600 patients with CKD (eGFR 15-49 mL/min per 1.73 m2) and NVAF receiving rivaroxaban, OAC with VKA, or no AC therapy, who are prospectively followed for a flexible duration with a minimal follow-up duration of 12 months until study end is announced (planned minimum 360 days / planned maximum 84 months).

The plan of the registry is to include at least 1600 patients with CKD and NVAF and rivaroxaban therapy or VKA therapy or no AC therapy.

The aim is to include at least 700 patients with rivaroxaban therapy and VKA therapy, respectively. Into the exploratory treatment arm of patients receiving no AC therapy about 100 patients will be included.

Study Timeline

• Study First Submitted: 2015-12-17
• Study First Submitted QC: 2016-01-21
• Study First Posted: 2016-01-26
• Study Start: 2016-04
• Primary Completion: 2022-01
• Study Completion: 2022-04-04
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-18
• Last Update Posted: 2022-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1700

Inclusion Criteria

• male and female patients, age ≥ 18 years
• CKD with eGFR 15 - 49 mL/min per 1.73 m2
• non-valvular atrial fibrillation (NVAF) with indication for anticoagulation therapy
• a treatment strategy for the ≥ 3 previous months before enrolment with either: rivaroxaban or VKA (OAC cohorts) or no anticoagulation (no AC cohort)
• informed consent
• availability for follow up
• life expectancy of ≥6 months

Exclusion Criteria

• exclusion criteria according to the local product information for the respective anticoagulation treatment
• planned treatment with other anticoagulants
• expected renal-replacement therapy within the next 3 months

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
major cardiovascular events (MACE)	12 month
major bleeding	12 month
decline in eGFR in mL/min per 1.73 m2	12 month
all-cause mortality	12 month
symptomatic venous thromboembolic events	12 month
net-clinical benefit (stroke and other thromboembolic events, major bleeding, and all-cause mortality)	12 month
TIA, stroke or systemic arterial embolism	12 month

Secondary Outcome Measures

Name	Time	Method
initiation of chronic renal replacement therapy	12 month
length of hospitalizations	12 month, 18 month
reasons for OAC therapy discontinuation	12 month, 18 month	descriptive analysis of reasons for therapy discontinuation (verbal description by investigator)
eGFR < 15 mL/min per 1.73 m2 (CKD Stage 5 Dialysis and Non-Dialysis)	12 month
doubling of serum creatine concentration	12 month
acute kidney injury (AKI) events defined as acute kidney injury associated with either hospitalization or emergency department visit, where AKI event is the lead diagnosis	12 month, 18 month
causes of hospitalizations	12 month, 18 month
eGFR decline of ≥ 30%	12 month
rates of hospitalizations	12 month, 18 month
persistence with OAC therapy	12 month, 18 month

Trial Locations

Locations (116)

Krankenhaus St. Josef Braunau; 🇦🇹 Braunau Am Inn, Austria

Medizinische Universitätsklinik; 🇦🇹 Graz, Austria

Allgemeines Krankenhaus der STadt Linz; 🇦🇹 Linz, Austria

Krankenhaus der Elisabethinen Linz; 🇦🇹 Linz, Austria

Medizinische Universität Wien; 🇦🇹 Wien, Austria

Meidzinische Universität Wien; 🇦🇹 Wien, Austria

Sozialmedizinischer Zentrum-Süd Kaiser-Franz-Josef-Spital; 🇦🇹 Wien, Austria

Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhügel; 🇦🇹 Wien, Austria

Centre Hospitalier EpiCURA-Baudour; 🇧🇪 Baudour, Belgium

CUB Hôpital ERASME; 🇧🇪 Bruxelles, Belgium

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